The American Cancer Society's estimates for breast cancer in the United States for 2016 are:                About 246,660 new cases of invasive breast cancer will be diagnosed in women.        About 61,000 new cases of carcinoma in situ (CIS) will be diagnosed (CIS is non-invasive and is the earliest form of breast cancer).        About 40,450 women will die from breast cancer.        
Breast cancer most commonly develops in cells from the lining of milk ducts and the lobules that supply the ducts with milk. Cancers developing from the ducts are known as ductal carcinomas, while those developing from lobules are known as lobular carcinomas. In addition, there are more than 18 other sub-types of breast cancer. Some cancers, such as ductal carcinoma in situ, develop from pre-invasive lesions. The diagnosis of breast cancer is confirmed by taking a biopsy of the concerning lump. Once the diagnosis is made, further tests are done to determine if the cancer has spread beyond the breast and to which treatments it may respond.
Most breast cancers are carcinomas, a type of cancer that starts in the epithelial cells that line organs and tissues like the breast. In fact, breast cancers are often a type of carcinoma called adenocarcinoma, which is carcinoma that starts in glandular tissue. Other types of cancers can occur in the breast, too, such as sarcomas, which start in the cells of muscle, fat, or connective tissue. In any case, however, the cancer, in its early and most treatable stages is a highly-localized structure within the tissue that makes up the breast. For that reason, a highly focused application of any curative regimen is desired; there is no need to treat the surrounding healthy cells. The scope of this embodiment of the instant invention relates to these localized cancerous tumors and not to, for example, inflammatory breast cancer. Because the selected structures for treatment are highly localized, there is no reason to subject the whole of the breast structure where the cancerous cells are contained within a defined volume within the whole of the breast. To the greatest extent possible, the ideal solution would deliver the therapeutic treatment only to affected tissue while leaving the healthy structures alone or minimally involved.
Chemotherapy is the use of drugs to destroy cancer cells, which work by stopping the cancer cells' ability to grow and divide. A chemotherapy regimen (schedule) consists of a specific treatment schedule of drugs given at repeating intervals for a set period of time. Chemotherapy may be given on many different schedules depending on what worked best in clinical trials for that specific type of regimen. It may be given once a week, once every two weeks (also called dose-dense), once every three weeks, or even once every four weeks. Common ways to give chemotherapy include an intravenous (IV) tube placed into a vein using a needle or in a pill or capsule that is swallowed. As is evident, however, such a treatment involves the whole of the circulatory system and all tissue in contact with the circulating blood receiving chemical agents from the IV tube or the whole of the digestive system and such tissue as receives the chemical agents by means of digestion. As such, a great many healthy structures are dosed with the chemotherapeutic chemical agents which have no need for treatment.
Chemotherapy is predominantly used for cases of breast cancer in stages 2-4, and is particularly beneficial in estrogen receptor-negative (ER-) disease. The chemotherapy medications are administered in combinations, usually for periods of three to six months. One of the most common regimens, known as “AC”, combines cyclophosphamide with doxorubicin. Sometimes a taxane drug, such as docetaxel, is added, and the regime is then known as “CAT”. Another common treatment is cyclophosphamide, methotrexate, and fluorouracil (or “CMF”). Most chemotherapy medications work by destroying fast-growing or fast-replicating cancer cells, either by causing DNA damage upon replication or by other mechanisms. However, the medications also damage fast-growing normal cells, which may cause serious side effects. Damage to the heart muscle is the most dangerous complication of doxorubicin, for example.
The side effects of chemotherapy depend on the individual, the drug(s) used, and the schedule and dose used. These side effects can include fatigue, risk of infection, nausea and vomiting, hair loss, loss of appetite, and diarrhea. Naturally, these side effects are undesirable and to avoid these side effects while still benefiting from the therapeutic effects the chemotherapy could cause would be highly desirable.
On a molecular level, the listed chemical agents used in chemotherapy cause changes in the molecular structure of cancerous cells. The molecules that make up the chemotherapeutic effectors interact with target biological systems through various physicochemical forces, such as ionic, charge, or dispersion forces or through the cleavage or formation of covalent or charge-induced bonds. These changes effected by physicochemical forces, necessarily assert field effects, i.e. electrostatic and magnetic field effects. Each of the changes involve the movement of charge from one molecular structure to another. Because of these physicochemical-induced movements of charge during interaction, detection of field effects present a record of the chemotherapeutic interactions.
Chemical reactions involve, among other things, the exchange of electrons between valence shell electrons to form or separate compound molecules. Movement of electrons is known as current and that electron movement forms corresponding magnetic fields. Electric and magnetic fields are fundamental in nature and can exist in space far from the charge or current that generates them. Every charged object sets up an electric field in the surrounding space. A changing magnetic field produces an electric field, as the English physicist Michael Faraday discovered in work that forms the basis of electric power generation. Faraday's law of induction describes how a time-varying magnetic field produces an electric field. Conversely, a changing electric field produces a magnetic field, as the Scottish physicist James Clerk Maxwell deduced. Thus, when a first charge moves from a valence shell of an atom, a second charge “feels” the presence of this movement due to the fields produced. The second charge is either attracted toward the initial charge or repelled from it, depending on the signs of the charges. Of course, since the second charge also has an electric field, the first charge feels its presence and is either attracted or repelled by the second charge, too. In short, every chemical reaction causes electrical and magnetic fields to form that are characteristic of that chemical reaction and those fields are detected by other electrons within a given proximity to those fields.
Several have postulated that the chemotherapeutic interactions between a chemical effector and a biological target may not require the presence of the effector itself. Even without the presence of the effector, the object is to induce the same changes in the target by generating field effects associated with effector molecules from signals sensed during action upon targets by effector molecules. By sensing the movement of electrons in successful chemotherapy through recording the generated fields resulting from that movement, the premise asserts that recreating those magnetic and electric fields is sufficient to produce the same therapeutic results without requiring the presence of the chemical effector.
Recognizing that effecting cellular level changes in biological targets by reproducing the suitable electrical and magnetic fields marks the pioneering works of the scientists of Nativis, Inc. as those works are set forth in white papers, patents and patent applications, the instant invention produces highly localized electrical and magnetic field effects. Reducing and eliminating tumors by producing magnetic and electric fields are the gravamen of several studies undertaken to examine the interaction between effector-molecule signals and biological targets. For example, PCT applications WO 2006/073491 A2 and WO 2008/063654 A2, both of which are incorporated by reference herein, teach the application of low-frequency time-domain signals to duplicate field effects the researchers had earlier recorded. These recorded signals comprise low-frequency time domain signals sensed and recorded as emanating from the interaction of one of several bio-active compounds and a biological target such as a matrix of cells (the researchers had isolated these signals observing the application of effectors to induce compound-specific effects in biological target systems). The following is a direct quote from United States Patent Published Application 2011/0195111 entitled “Aqueous Compositions and Methods” and owned by Nativis, Inc.:                PCT application WO 2006/073491, published Jul. 13, 2006 discloses studies in which (a) low-frequency time-domain signals recorded for L(+) arabinose were shown to induce the araC-PBAD bacterial operon, as discussed on pages 47-50 of the application, with respect to FIGS. 30C-30F; (b) low-frequency signals recorded for glyphosphate, the active ingredient in a well-known herbicide, were shown to substantially inhibit stem growth in pea sprouts, as discussed on pages 50-51 of the application, with respect to FIGS. 31 and 32A and 32B; (c) low-frequency signals recorded for gibberelic acid, a plant hormone, were shown to significantly increase average stem length in live sugar pea sprouts, as discussed on pages 51-53 of the application, with respect to FIG. 33; and (d) low-frequency signals recorded for phepropeptin, a proteasome inhibitor, were shown to decrease the activity of the 20S proteosome enzyme, as discussed on pages 53-54 of the application, with respect to FIG. 34.        WO 20081063654 A2, published May 9, 2008, details studies in which low-frequency time-domain signals for the anti-tumor compound paclitaxel, generated in accordance with methods disclosed herein, were shown to be effective in reducing tumor growth in animals injected with glioblastoma cells, when the animals were exposed to an electromagnetic field generated by the signal over a several-week period.        Among the findings from the studies described above is that the ability of agent-specific, time-domain signals to transduce (affect) a biochemical or biological target system can be optimized by a number of strategies. One of these strategies involves scoring recorded time-domain signals by one or more scoring algorithms to identify those signals that contain the highest spectral information. This scoring is used to screen recorded time-domain signals for those that are most likely to give a strong transduction effect. An improvement in this strategy is to record time-domain signals at each of a number of different magnetic-signal injection conditions, by injecting different levels of white noise or DC offset during recording, and scoring the resulting signals for highest spectral information. These strategies are detailed in both of the above-cited PCT applications.        A third strategy, disclosed in the '654 application, is designed particularly for applications in which a recorded time-domain signal is intended for transducing an animal system, for example, for treating a disease condition in a subject. The strategy involves screening time-domain signals for their ability to effectively transduce an in vitro target system that includes at least some of the critical biological response components of the animal system. The strategy has the advantage that a large number of candidate signals can be easily screened for actual transduction effect, to identify optimal transducing signals. The strategy is preferably combined with one or both of the above signal-scoring methods, using the highest-scoring signals as candidates for the in vitro transduction screening.        Independently, a number of scientific groups have reported on the structure and stability of clustered water in pure and solute-containing water samples, including structured water formed at interfaces. See, for example, studies cited in the websites of Dr. Rustum Roy, late of the Pennsylvania State University (rustumroy.com); Dr. Gerald Pollack at the University of Washington (www.depts.washington.eduibioe/people/core/pollack.html)); Dr. Martin Chaplin of the London South Bank University (1.1sbu.ac.uk/wate); and Dr. Emilio Del Guidice (isi.it/progetti/workshop-complexity09/pres_DelGiudice.pdf). Among the findings of these groups is that water interacts with electromagnetic radiation to form stable macroscopic structures that can be detected by a number of physical and spectroscopic tools; (See, for example, del Guidice, E., et al., Physical Review, 74:022105-1 (2006); Pollack, G., uwtv.org/programs/displayevent.aspx?rID=22222): Chai, B. et al, J. Phys. Chem. B, 2009, 113:13953-13958; Rao, M. L., et al., Current Science Research Communications, 98(1); 1500, June, 2010.        
The application sets out a method of forming an aqueous composition effective to produce an agent-specific effect on an agent-responsive chemical or biological system, when the composition is added to the system. The method includes the steps of:                (a) placing an aqueous medium within the sample region of an electromagnetic-coil device; and        (b) exposing the aqueous medium to a magnetic field generated by supplying to the device, a low-frequency, time-domain agent-specific signal, at a signal current calculated to produce a magnetic field strength in the range between 1 G (Gauss) and 10.sup.-8 G, for a period sufficient to render the aqueous medium effective to mimic one or more agent-specific effects on an agent-responsive system.The low-frequency, time domain signal used in step (b) may be produced by the steps of:        (i) placing in a sample container having both magnetic and electromagnetic shielding, an aqueous sample of the agent, wherein the sample acts as a signal source for low-frequency molecular signals; and wherein the magnetic shielding is external to a cryogenic container;        (ii) recording one or more time-domain signals composed of sample source radiation in the cryogenic container, and        (iii) identifying from among the signals recorded in step (ii), a signal effective to mimic the effect of the agent in an agent-responsive system, when the system is exposed to a magnetic field produced by supplying the signal to electromagnetic transducer coil(s) at a signal current calculated to produce a magnetic field strength in the range between 1 G to 10.sup.-8 G.        
The inventor of the instant invention makes no assertion as to this science but adopts each of the recited applications in their entirety by the above set-out references. Rather, the inventor, acknowledging the science those references contain seeks, instead, to teach and claim the use of a particularized garment having a plurality of solenoids for the selective propagation of low-frequency, time-domain agent-specific signals throughout selected tissue of a human patient for therapeutic purposes. Nonetheless, the inventor notes that Nativis' flagship therapy and device known together as Voyager is amid clinical trials to “assess the effects of the Nativis Voyager™ therapy in patients with recurrent GBM who have either failed standard of care or are intolerant to therapy. The study will enroll and treat up to 64 subjects of which 32 will be treated with the Voyager therapy alone (monotherapy) and 32 will be treated with Voyager plus concurrent chemotherapy. Safety and clinical utility will be evaluated. See, “A Feasibility Study of the Nativis Voyager™ System in Patients with Recurrent Glioblastoma Multiforme (GBM)” having ClinicalTrials.gov Identifier: NCT02296580.
There is a need for a garment to administer therapeutic electromagnetic fields effectively and discretely to women afflicted by breast cancer. Psychologists recognize a historic aversion among women to be identified as undergoing treatment for breast cancer. The earliest research on the psychological impact of breast cancer focused its attack on femininity, with amputation of the breast, and subsequent threat to sexual attractiveness. In addition to these concerns, the life-threatening nature of cancer itself contributed to psychological distress. The stress of breast cancer has been described as arousing depression, anxiety, and anger. In some of the first systematic and comparative studies, mastectomy patients were found to be more distressed than women with benign lumps, and often this distress persisted for more than a year following surgery. Patients treating for breast cancer report changes in life patterns that resulted from the diagnosis and surgical treatment of breast cancer, including insomnia, recurrent nightmares, loss of appetite, difficulty returning to usual household activities and work, and inability to concentrate.
Primary brain cancer develops from cells within the brain. Primary brain tumors are tumors that form from cells within the brain. The tumors are categorized by the type of cell in which it first develops. Surgery for brain cancer is often the first step in the treatment process for brain tumors. Deciding whether to remove a tumor depends on if it can be done safely, and how much normal brain tissue is involved. In some cases, surgery may be performed to reduce the tumor size, but may not remove all cancerous tissue. For operable brain tumors, surgically removing cancer could cure early stage disease.
The efficacious therapeutic treatment of brain cancer presents many of the same concerns relative to the probability of damage to surrounding tissue. It is the natural object of therapy to preserve as much of the healthy surrounding tissue while cleansing the healthy grey matter of any trace of malignant tissue. To that end, invasive excision of tissue is only tolerated due to the extraordinary risk that cancerous cells present. This tradeoff between excision of cancerous cells and the possible damage to healthy adjacent cells drives the search for noninvasive treatment of brain tumors.
Just as in the case of the breast, the head presents itself as a protuberance presenting on several aspects the surface of the volume of tissue the head contains. As such, unlike organs the torso contains, the brain resides very close to the outer surface of the head. Ideally, the brain thus resides within the ready scope of the influence of an electromagnetic coil and any given tissue within the brain might be subjected to such magnetic influence from more than one side. Thus, for any given volume of tissue within the brain, distinct magnetic fields might be superimposed upon that volume by means of distinct magnetic coils. The treatment of brain cancer can be effected by feeding low-frequency signals into a plurality of coils fixed relative to the surface of the head, just as therapy can be achieved by a plurality of magnetic coils fixed on the surface of the breast. While noninvasive treatment usually means treatment without surgery, ideally noninvasive treatment of breast or brain cancer means that the treatment also does not invade the life activities of the treated patient. For this reason, it is desired that the treatment of breast or brain cancer is to be as inconspicuous as possible. To avoid the stigma of any clear therapy for breast cancer, what is needed in the art is a means of making the therapy less evident while not in any way diminishing the effectiveness of that therapy. What is needed in the art is a means of facilitating the therapeutic use of solenoids near the targeted tissue of the brain or breast without unwarranted disclosure of the presence of the tumor within the targeted tissue.